A Study to Compare the Safety and Effectiveness of 2 Doses of Levofloxacin Given for Different Time Periods in Patients With Pneumonia
The purpose of this study is to evaluate the effectiveness and safety of two antibiotic regimens in the treatment of community-acquired pneumonia in non-hospitalized adult patients. A 5-day course of 750 milligrams of levofloxacin given once daily will be compared to a 10-day course 500 milligrams of levofloxacin given once daily.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Multicenter, Double-Blind Randomized Study to Compare the Safety and Efficacy of Levofloxacin 750 mg Once Daily for Five Days vs. Levofloxacin 500 mg Once Daily for 10 Days in the Treatment of Mild to Severe Community-Acquired Pneumonia in Adults|
- Clinical response rates based on signs and symptoms at posttherapy visit.
- Microbiologic eradication rates at posttherapy visit; Clinical response rates (chest x-ray findings and signs/symptoms) and microbiologic eradication rates at poststudy; Incidence of adverse events
|Study Start Date:||March 2001|
|Study Completion Date:||June 2002|
Levofloxacin is an antibiotic that is approved by the FDA for the treatment of sinusitis, chronic bronchitis, skin infections, urinary tract infections, and community-acquired pneumonia. This multicenter, double-blind (neither the patient nor the study doctor will know the dose of levofloxacin being administered) study evaluates the effectiveness and safety of two antibiotic regimens in the treatment of community-acquired pneumonia in adult patients. A 5-day course of 750 milligrams of levofloxacin given once daily will be compared to a 10-day course 500 milligrams of levofloxacin given once daily. Patients receive levofloxacin by mouth or through a vein depending on the severity of their pneumonia. Patients are assessed after 3 days of treatment; treatment is discontinued if no significant improvement is noted. Patients showing signs of improvement continue in the study, with assessments on study days 12-16, and 17-21 (posttherapy visits), and 31-38 (poststudy visit). Effectiveness is assessed by measuring the ability of the study drug to eliminate bacteria causing pneumonia and to reduce the signs and symptoms of pneumonia. Chest x-rays and laboratory tests for presence of bacteria are performed during the study. Safety evaluations (incidence of adverse events, physical examinations, laboratory tests) are performed throughout the study. The study hypothesis is that levofloxacin administered at a higher dose for a shorter duration is at least as effective as levofloxacin administered at a lower dose for a longer duration in the treatment of community-acquired pneumonia and is generally well-tolerated.
Levofloxacin, 500 milligrams (mg) by mouth or through vein daily for 10 days or 750 mg by mouth or slowly through a vein daily for 5 days
|Study Director:||Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial||Johnson & Johnson Pharmaceutical Research & Development, L.L.C.|